Qualified Person - UK

We are seeking a Qualified Person in our Quality Assurance team to be based in person from our Cambridge, UK office and report to Head, Quality - UK. You will be responsible for certification and release of medicinal product batches. You will support Quality Management Systems and compliance activities. 

Responsibilities:

• To support Quality Assurance in efficient functioning and implementation of all Quality plans at site
• Ensuring that all activities are performed in accordance with the regulatory and legal requirements and in compliance to the requirements of the current GMP, GDP, company SOP’s and Health and safety policies / SOP’s
• Creation, implementation, monitoring, review and continuous improvement initiatives of cGMP’s, Quality Management Systems (QMS) and procedures as assigned / required by Head of Quality
• Conducting External Audit system, liaising with clients and auditors, ensuring audits are planned and performed within given timelines
• Reviewing audit reports for completion including audit close out, following up on audit response plan, ensuring all actions are completed and within given timelines
• Providing QP support in the evaluation of investigation and documentation pertaining to quality of products or processes e.g change controls, deviations, quality incidents, OOSs, OOTs, CAPAs, complaints, recalls pertaining to quality of product or process as applicable
• Review and decision making on the fate of change controls, deviations, complaints, CAPA’s related to vendors and service providers
• Review and approval of periodic product quality review and identify any risk associated with product / facility during the review period
• Undertaking the duties of a Qualified Person in accordance with EU directives 2001/83/EC and 2001/82/EC, products where permitted by the Cambridge site MIA
• Motivating, coaching and mentoring Quality team members and providing direction and guidance on quality and GMP issues

Working with all members of staff and the senior management to develop, improve and maintain the positive quality culture within Dr. Reddys, Cambridge

Member of the Quality team responsible for ensuring the cGMP compliance and Quality systems in place at Dr. Reddys, Cambridge is efficient, effective and enable the organization to achieve its Quality, Regulatory and Business objectives

Working as a Responsible Person (import) (RPi) as described in regulations 45AA and 45AB of the Human Medicines Regulations 2012 (as amended)

Assist with the activities required to add Biologics as a permitted product category to the Cambridge site MIA

Undertaking any other duties within Quality, which may be requested by the Head of Quality, for which training and / or an explanation has been provided and understood

Education & Experience:

• Master Degree in Pharmacy, Pharmaceutical Chemistry, Life Sciences or related field

• Eligible to act as a Qualified Person under applicable UK/EU regulations

• Significant Quality Assurance experience in pharmaceutical industry

Key Skills & Competencies:

• GMP/GDP expertise 

• Strong auditing and compliance knowledge 

• Analytical decision making 

• Stakeholder management 

• Excellent communication skills